Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01011374
Other study ID # FVF4638s
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received November 9, 2009
Last updated March 16, 2011
Start date November 2009
Est. completion date November 2013

Study information

Verified date March 2011
Source Retina Associates of Cleveland, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date November 2013
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the full duration of the study

- Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam

- Age 18 years or over

- Central macular edema on clinical exam as well as imaging with a central thickness of = 250 microns

- Visual acuity ranging from 20/8000 to 20/40

- Media clarity and patient cooperation sufficient to allow adequate testing utilizing OCT and FA

- No previous treatment that might compromise or confound assessment of the study outcomes

- Ability to speak and read English

Exclusion Criteria:

- Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements

- Concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise

- History of grid/focal laser in the study eye

- History of vitreal surgery

- Previous treatment with triamcinolone acetonide in either eye

- Previous use of bevacizumab, pegaptanib, or ranibizumab in either eye

- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders

- History of cerebrovascular accident within 1 year prior to Day 0

- Inability to comply with study or follow-up procedures

- Any cognitive defect as a result of mental disease, previous injury, or disease process that may interfere with interpretation of study results

- Visual acuity better than 20/40

- Pregnancy (positive pregnancy test) or lactation

- Inadequate contraception in premenopausal women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ranibizumab (Lucentis)
0.5 mg, administered intravitreally every 4 weeks

Locations

Country Name City State
United States Retina Associates of Cleveland Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Retina Associates of Cleveland, Inc Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks. 24 weeks No
Secondary Secondary outcome measures are change in macular edema measured by OCT and estimated by central retinal thickening and correlations between change in visual acuity, depression, and retinal findings such as neovascularization, rubeosis, and perfusion. 24 weeks No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A